(51 days)
The NBD Head Screws are an accessory that is intended to support the head frame in stereotactic procedures. The head frames are supported by either a three point-of-contact or four point-of-contact position depending on the frame design.
The NBD Head Screw is a single-use threaded clear anodized aluminum screw which is manufactured in lengths ranging from 33mm-57mm.
The provided 510(k) summary for the NBD Head Screw does not contain information about acceptance criteria or a study performed to prove the device meets such criteria.
The document states: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for this device." This indicates that there were no specific performance metrics or thresholds established for this device by regulatory bodies at the time of submission.
Instead of performance studies, the clearance for the NBD Head Screw was based on substantial equivalence to legally marketed predicate devices. This means the manufacturer demonstrated that their device is as safe and effective as existing, legally marketed devices with similar intended use, materials, and design, rather than through meeting specific performance metrics via a new study.
Therefore, the requested information cannot be extracted from the provided text.
Here's why each point cannot be answered:
- A table of acceptance criteria and the reported device performance: Not provided. The submission states there are no applicable performance standards.
- Sample size used for the test set and the data provenance: No test set or performance study is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical accessory, not an AI or imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical accessory, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable, as this is not an algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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K050377
510(k) Summary of Safety and Effectiveness
In Accordance with SMDA of 1990
NBD Head Screw
January 21, 2005
Company: NBD, LLC 605 Industrial Court Woodstock, GA 30189
Trade Name: NBD Head Screw
Common Name: Head Screw
Product Code and Regulatory Classification:
Stereotaxic Instrument 882.4560 HAW:
Product Classification:
Class II
Intended Use:
The NBD Head Screws are an accessory that is intended to support the head frame in stereotactic procedures. The head frames are supported by either a three point-of-contact or four point-of-contact position depending on the frame design.
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Device Description:
The NBD Head Screw is a single-use threaded clear anodized aluminum screw which is manufactured in lengths ranging from 33mm-57mm.
Performance Data:
No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for this device.
Substantial Equivalence:
The NBD Head Screw is similar in intended use, material, safety, and efficacy to the Elekta Stereotactic head screw accessory, K972324, as well as accessories currently in commercial distribution by Radionics and Leibinger, and Ohio Medical Instruments.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and wings. The seal is black and white.
APR 7 2005 Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tim B. Lusby General Manager New Business Development, LLC 605 Industrial Court Woodstock, Georgia 30189
Re: K050377
Trade/Device Name: NBD Head Screw Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 25, 2005 Received: March 28, 2005
Dear Mr. Lusby:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) premainter is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tise stated in the encrosule) to regars neatment date of the Medical Device Amendments, or to commerce prior to may 20, 1976, the enavitance with the provisions of the Federal Food. Drug, devices mat nave been recuired in accession as a proval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvinces of the general controls provisions of the Act. The You may, merciole, market me do received on the requirements for annual registration, listing of general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classified (see above) into s. Existing major regulations affecting your device of Day ( it may be subject to such additional concerns. Title 21, Parts 800 to 898. In addition, FDA call be found in the Code of Peacharting your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not meant Please be advised that i Dri's issuales of a backer.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a decemmanon that Jour seen agencies. You must or any Federal statutes and regulations daminities. but not limited to: registration and listing (21 comply with an the Act 3 requirements, mercesses and actually and setting became CFR Part 807), adoning (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Tim B. Lusby
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your artise as walnes of your device to a legally
premarket notification. The FDA finding of substantial engineer of your premarket notification. The FDA Intellig of Subscantal or and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs in the may of the may of the support of a note as not the regulation ent If you desire specific advice for your ac not on on on on on one more the regulation entitled,
contact the Office of Compliance at (240) 276-0120 . . Also, please note the vi contact the Office of Compliance at (216) 276 - 1 (21CFR Patt 807.97). You may obtain "Misbranding by reference to premarket noutheation" (21 %) from the Division of Small other general information on your responsionAssance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Pisolotanos artist consection of the new home in the
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K050377
Device Name: NBD Head Screw
Indications For Use: The NBD Head Screws are an accessory that is intended to support the head frame in stereotactic procedures. The head frames are support the near a three point-of-contact or four point-ofcontact position depending on the frame.
AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Eith
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ision sign-Oil) Civision of General, Restorative and Neurological Dev
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).